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news.Biovest International, a majority-owned subsidiary of Accentia Biopharmaceuticals, has reported encouraging blinded results from its randomized controlled pivotal Phase III fast-tracked clinical trial of BiovaxID for the treatment of indolent follicular non-Hodgkin's lymphoma, an often fatal blood cancer.
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The company reported blinded disease-free survival data for those patients that have completed 36 months of follow-up subsequent to randomization in both the treatment and control arms, with one arm demonstrating 100% improvement in disease-free survival over the other arm. Disease-free survival (how long patients remain in cancer-free remission) is the primary endpoint of the study.
Steven Arikian, chairman and CEO of Biovest International, said: “Although these results are blinded, this data shows two distinct populations in the study, with unequivocal evidence of a difference in disease-free survival among the two arms. This is in direct contrast to previous anti-NHL vaccine failures which showed little difference between the treatment arm and the control arm.
“Based on the similar pattern to our Phase II data, we have a high degree of confidence that the cohort demonstrating superior disease-free survival represents the BiovaxID arm.”